Novian Health

  • About Us
    • Overview
    • Management
    • Board Of Directors
    • Investors
  • Research & Products
    • Novilase® Breast Therapy
    • eIFU
    • Clinical Trials & Registries
    • Publications
    • Certificates
    • Intellectual Property
  • News
    • News & Press Releases
    • Media Coverage
    • Upcoming Events
  • Contact
    • Careers

Novian Health Begins Breast Cancer Clinical Trial (12 April 2012)

April 12, 2012 by Novian Health

April 12, 2012
Contact: Liz Dowling, (415) 3888-2794
Dowling & Dennis Public Relations
E-mail:Liz@DowlingDennis.net

Rose Breast Center Initiates Study of Laser Therapy for Breast Cancer

CHICAGO–Novian Health, developer of Novilase® Breast Therapy, announced the company has begun a multicenter clinical trial on the use of Novilase® Interstitial Laser Therapy (ILT) for the destruction of malignant breast tumors.The first facility to participate in the multi-center clinical trial is the renowned Rose Breast Center, in Denver, under the study direction of Barbara Schwartzberg, M.D.

Novilase ILT is an image-guided, minimally invasive alternative for lumpectomy. It is used to ablate (destroy) small breast tumors.The new clinical trial is the first stage of a two stage study as part of an FDA premarket approval (PMA) process.The trial follows a successful, single center feasibility study on Novilase ILT for treatment of malignant breast tumors.The company said it will soon begin a similar clinical trial in Europe

Novian Health has previously received FDA 510(k) clearance for the treatment of breast fibroadenomas and currently offers Novilase at Rose and other breast centers around the country that are participating in its ABLATE registry.

This study will evaluate the rate of complete tumor ablation (destruction by laser) of breast cancers that are up to 2 centimeters. It will also examine the correlation of the pathology of post-ablation lumpectomy specimens with MRI, mammography and ultrasound in detecting any residual tumor.

“The goal of this study is to evaluate whether minimally invasive laser ablation of early-stage breast cancer is as effective as a traditional surgical lumpectomy,” said Dr.Barbara Schwartzberg, Chair of Cancer Services at Rose Medical Center. “With laser, this may be performed more conveniently, with less pain and with less deformity.I am proud to offer this as an option for patients at the Rose Breast Center, continuing our tradition of providing the latest technologies and treatments.”

“All of us at Novian Health are excited to begin this multicenter trial and to be working with the prestigious Rose Breast Center, as part of a process aimed at making this minimally-invasive therapy for breast cancer available to women,” said Henry “Chip” Appelbaum,President and CEO of Novian Health.

Novilase ILT may provide women who have early‐stage breast cancer with the option of an ablation procedure that could result in a lower rate of residual disease and thus fewer re-treatments, a shorter recovery time, minimal scarring or breast deformity.Novilase does not precludeany additional treatment, if necessary,such as the use of radiation therapy and/or systemic adjuvant therapy, as per standard of care.
Given the overall shift to more precise and targeted cancer treatments,many women have an increased expectation for less invasive procedures.Just as needle-core breast biopsy has provided a new alternative to surgical biopsy, Novilase ILT may be another option for women with breast cancer who are considering lumpectomy.

More than 600,000 lumpectomies are performed in the United States annually, including both malignant and benign tumors.The company estimates that approximately 50% of malignancies meet the inclusion criteria for this study.
The trial is registered on www.ClinicalTrials.gov(#NCT01478438).

Related Posts

  • Denver: Rose Medical Enters in Novilase Cancer Clinical Trial (12 April 2012)
  • Novian Health Founder Is Honored as Breast Cancer Leader by Chicago Komen Affiliate (20 Oct 2011)
  • Novian Health Closes $11 Million in Funding for Breast Cancer Clinical Trials (04 Feb 2013)
  • Breast Cancer Clinical Trial of Laser Ablation Treatment Shows Promising Results for Patients (10 Dec 2015)
  • Novian Health Awarded New Patent for Breast Cancer Treatment Technology (05 Dec 2013)

Filed Under: Press Release 2012

Recent Posts

  • Novian Health Earns New Product Innovation Award for Novilase Breast Therapy (6 December 2022)
  • Novian Health Gains FDA Breakthrough Designation for Novilase Breast Therapy (28 September 2021)
  • Novian Health Inc. Announces the Second Close of Convertible Note Financing (23 August 2021)
  • Novian Health Inc. Announces the First Close of Convertible Note Financing (28 July 2021)
  • Novian Health to Present at the Cavendish Global Summit on February 25, 2021 (12 February 2021)

ARCHIVES

  • December 2022
  • September 2021
  • August 2021
  • July 2021
  • February 2021
  • September 2020
  • June 2020
  • September 2019
  • July 2019
  • June 2019
  • December 2015
  • December 2014
  • September 2014
  • May 2014
  • December 2013
  • April 2013
  • February 2013
  • April 2012
  • October 2011
  • September 2011
  • July 2011
  • November 2010
  • December 2009
  • November 2009
  • October 2009
  • May 2009
  • June 2008
  • March 2008
  • October 2007
  • June 2007

Categories

  • Archives
  • Press Release 2011
  • Press Release 2012
  • Press Release 2013
  • Press Release 2014
  • Press Release 2015
  • Press Release 2019
  • Press Release 2020
  • Press Release 2021
  • Press Release 2022

CONTACT US

Novian Health Inc.
(Headquarters)
222 W Merchandise Mart Plaza
Suite 228
Chicago, Illinois 60654
Office: 312-266-7200
Fax: 312-266-7202
Email: info@novianhealth.com

    

LATEST NEWS

  • Novian Health Earns New Product Innovation Award for Novilase Breast Therapy (6 December 2022)
  • Novian Health Gains FDA Breakthrough Designation for Novilase Breast Therapy (28 September 2021)
  • Novian Health Inc. Announces the Second Close of Convertible Note Financing (23 August 2021)
  • Novian Health Inc. Announces the First Close of Convertible Note Financing (28 July 2021)
  • Novian Health to Present at the Cavendish Global Summit on February 25, 2021 (12 February 2021)

Copyright © 2025 Novian Health. All Rights Reserved. Privacy Policy.